1Quality unit oversight
The annual product quality review procedure was inadequate.
Inspection Record
PNP Pharmaceuticals Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The electronic system was not validated for its intended use.
3Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
4Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
5Other quality system
The system for reviewing, revising, and approving standard operating procedures was inadequate.
6Complaint and recall handling
Investigations into deviations, reports, and/or follow-up actions were inadequate. The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
7Equipment and facility
The validation of equipment or the planned maintenance of equipment was inadequate.
8Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-04-11. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
